Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and bulbar muscular atrophy (SBMA)"

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223924

Enrollment

1890

Registered

2018-06-01

Start date

2017-11-02

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal and bulbar muscular atrophy

Interventions

investigational material(s) Generic name etc : Leuprorelin Acetate INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Do

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All SBMA patients who have been confirmed as receiving the drug

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Percentage of Participants who had One or More Adverse Drug Reactions Adverse drug reaction refers to adverse events related to administered drug. Percentage of participants who have the adverse drug reactions that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported. Timeframe; Up to 1 Year Percentage of Participants who had One or More Serious Adverse Events Percentage of participants who have the serious adverse events that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported. Timeframe; Up to 1 Year	—

Measure

Time frame

Percentage of Participants who had One or More Adverse Drug Reactions Adverse drug reaction refers to adverse events related to administered drug. Percentage of participants who have the adverse drug reactions that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported. Timeframe; Up to 1 Year Percentage of Participants who had One or More Serious Adverse Events Percentage of participants who have the serious adverse events that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported. Timeframe; Up to 1 Year

—

Secondary

Measure	Time frame
Percentage of Participants without Death Event Percentage of participants without events of death at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years) Percentage of Participants without Pneumonia Requiring Hospitalization Event Percentage of participants without events of pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years) Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization Percentage of participants without composite events of death and pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years) Percentage of Participants without Dysphagia Events Percentage of participants without events of dysphagia at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years)	—

Measure

Time frame

Percentage of Participants without Death Event Percentage of participants without events of death at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years) Percentage of Participants without Pneumonia Requiring Hospitalization Event Percentage of participants without events of pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years) Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization Percentage of participants without composite events of death and pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years) Percentage of Participants without Dysphagia Events Percentage of participants without events of dysphagia at final assessment point (up to 8 years from initiation of treatment) will be reported. Timeframe; At final assessment point (up to 8 years)

—

Countries

none

Contacts

Public ContactClinical Trial Information Contact for

Takeda Pharmaceutical Company Limited

smb.Japanclinicalstudydisclosure@takeda.com+81-6-6204-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026